The Quality Assurance Manager manages all aspects of Quality Assurance relating to human resource and operational objectives, including development of QA and quality improvement plans, validating quality processes, and preparing quality documentation reports, among other matters.
Accomplishes quality assurance human resource objectives by:
Orienting, training and coaching employees;
Communicating job expectations;
Planning, monitoring, appraising and reviewing job contributions of QA; and
Contributing information and analysis to strategic plans and reviews;
Preparing and completing action plans;
Implementing production, productivity, quality and customer-service standards;
Identifying and resolving problems;
Determining system requirements; and
Develops quality assurance plans by:
Identifying critical control points and preventive measures;
Establishing critical limits, monitoring procedures, corrective actions and verification procedures; and
Validates quality processes by:
Establishing product specifications and quality attributes;
Determining operational and performance qualification; and
Writing and updating quality assurance procedures.
Maintains and improves quality by:
Completing company, system, compliance and clinical site audits; and
Collaborating with other members of management to develop new training methods.
Prepares quality documentation and report by:
Collecting, analyzing and summarizing information and trends including failed processes, corrective actions and re-validations.
Updates job knowledge by:
Studying trends in and developments in quality management;
Enhances department and organization reputation by:
Accepting ownership for accomplishing new and different requests; and
Exploring opportunities to add value to job accomplishments.
Bachelor’s degree; Master’s preferred
Excellent oral and written communication, organizational and planning skills
Detail-oriented, thoroughness and dealing with complexity
Willing and able to travel up to 20%
A minimum of 5 years of experience in quality assurance management
Internal Number: 0002
About Total Clinical Trial Management
Total Clinical Trial Management (TCTM), is a full service contract research organization based in Dallas, Texas. TCTM has a wide range of therapeutic expertise with recent areas of focus including pain, orthopedic injury, dermatology, cosmetics, over-the-counter (OTC) and generic studies.
Dermatolgy, Ophthalmology, Acute Pain, Women's Health, Aesthetics, Gastroenterology, and Ophthalmology